WWW.UK.X-PDF.RU

˲ - , ,

 
<< HOME
CONTACTS




( )
.: (050)697-98-00, (067)176-69-25, (063)846-28-10
׸

( )
.: (050)697-98-00, (067)176-69-25, (063)846-28-10
׸
 >>  . C 03.00.00
Pages:   || 2 | 3 | 4 |

˲ʲ Ҳ ò/ò Ҳ (ICH Q5) - 42- :2013 ̳ ' - 42- ...

-- [ 1 ] --

˲ʲ

Ҳ

ò/ò Ҳ

(ICH Q5)

- 42- :2013

̳ '

- 42- 2013

1 :

-Ͳ : . , . .

( ); . ; . , - . , , ; . , - . , , ; . , - . , , ; . , - , ; . , - .

, ; . , - . ; . ; . : ̳ ' 2 Ҳ: ̳ ' _______ ______ 3 :

CPMP/ICH/138/95 (ICH Topic Q5) Quality of Biotechnological Products:

Stability Testing of Biotechnological/Biological Products ( : / ) (MOD) (en)

4

̳ ' , 2013 II - 42- 2013 .

V 1 3 5 C / 9

1. 9

2.

3. 10

4. 10

4.1. (-) 10

4.2. 11

4.3. ˳ (

   

ֲ

. [1].

(CTD) [2], , , , 㳿, . ֳ , , .

/ . , , . , / , , , , , '. , , , , . / .

, / , , , , . , , / , IV - 42- 2013 (, ). , .

() CPMP/ICH/138/95 (ICH Topic Q5) Quality of Biotechnological Products: Stability Testing of

Biotechnological/Biological Products ( :

/ ) [3], / .

, , , . .

, :

CPMP/ICH/138/95 (ICH Topic Q5) Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products ( : / ) [3].

, , ̳ ' .

, .

, . , ; N.

:

- 1.5-2003 . , , V - 42- 2013 [5], 42-1.0:2005 . . [6];

- , , , , , , , , 1.5-2003 . , , [5] 1.7-2001 . [7]. ;

- C / ; CPMP/ICH/138/95 [3], Glossary;

- 10 CPMP/ICH/138/95 [3] Glossary. . , , ;

- , ;

- , ;

- , : , , , ; , , , , / , , , - , ;




140 .


VI - 42- 2013

- , ;

- (marketing application) (application for marketing authorisation) ;

- - (package inserts) ' ;

- , .

/ , .

, . , / , . ' / , . ( ) , .

- , . ;

( , , , ) , / , , . , .

   

() , ( ) / , , , . .

/ , , , .

/ , , , , , .

' ( ), , / / , - 42- 2013 , -, , - , , , () / , , .

2 - 42- 2013

Ͳ

:

. . 2001 .

. . 1. 2004 .

. . 2. 2008 .

. . 3. 2009 .

. . 4. 2011 .

CPMP/ICH/2736/99 (ICH Topic Q1A (R2)) Note for Guidance on Stability Testing:

Stability Testing of New Drug Substances and Products, 2003 ( , 2003).

CPMP/QWP/122/02 Rev 1 corr. Guideline on stability testing: stability testing of existing active substances and related finished products, London, 17 December 2003

( : , , 17 2003).

- 42-3.3-2004 ˳ . .

CPMP/ICH/365/96 (ICH Topic Q6B) Note for Guidance on Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products, September 1999 ( : / , 1999).

/ICH/367/96 (ICH Topic Q6A) Note for Guidance Specifications: Test

Procedures and Acceptance Criteria for New Drug Substances and New Drug Products:

Chemical Substances, 2000 ( : : , 2000).



Pages:   || 2 | 3 | 4 |
 
 >>  . C 03.00.00
:

3 (80) : 2013 330.111.6:658.821 65 , ³ -̲ ֲ ֲ Ͳί ֲ Ͳ - . ,...

̳ ³ ԲͲ ί ³ [535+681.7]:615.47 22.34:5 48 : . . , . . , . . , . . , . . ³ ̳ ( 5 24 2009 ). : . . , , ; . ....

㳿 㳿 (): . .. Ͳ ʲ ˲ - 6.040106 , 3 19 2011. . .. ...

ֲ ̲ ò . .. в 595.422:630*27(477) ˲ٲ PHYTOSEIIDAE (PARASITIFORMES, MESOSTIGMATA), ʲ ʲ Ͳ IJ ˲ 03.00.08 2008 㳿 㳿 . .. ...

. ., . . - 2005 . ., . . ò - , , 2005 591.5:612(075.8) 28.903,173 75 ...

10 2012 () 2012 . 858 . : . / ., ., .; .: , 2009.290.. . -140 - : / ...

.., .. . : , , , ...

.. .. ̳ , ϲ 2 371.32:371.72(075.8) 75.173 65 : , , ³ ...

˲Ѳ ˲˲ֲ : IJ, 2008. . 112 630.453 . . ̪1, . . ˪ʲ2 * ̲ ʲ ʲ ί Ҳ 1. - . . . 2. IJ 1974 2006 . 4 () 5 ...

. , . , . , . ˳, . , . , B. dz, . ij, . , . , . , . , . 12- from the INTERREG III B CADSES Project...




( )
.: (050)697-98-00, (067)176-69-25, (063)846-28-10
׸


 
<<     |    
2013 www.uk.x-pdf.ru -